Many types of specimen bags are presently available for use in establishing chain-of-custody of a specimen without tampering. Such specimen bags are used for collecting a specimen at a remote location which is to be analyzed at another location, such as a laboratory, and for ensuring that the specimen is not contaminated or tampered with during transfer or storage of the specimen. Moreover, specimen bags are particularly useful for collecting biological specimens such as urine, blood, and the like, but can also be used in the collection of other type specimens such as for water or pollutant analysis, agricultural analysis or the like. In any of these cases, it is important that it can be established that the specimen was not tampered with between the taking of the specimen and the analysis of the specimen to ensure accurate and verifiable results.
Typically, for collecting a specimen, the specimen is collected at a remote location and is sealed within a specimen container such as a vial or the like. Then, a specimen label is normally adhered to the vial so as to identify the specimen. Such a label may also provide the dual function of sealing the vial and providing a tamper-indicating means by which opening the vial will result in destruction of the label. After the specimen has been labeled, the vial will be placed within a specimen bag. Such a specimen bag, as in the prior art, typically includes a sealing means such that the inside of the bag can be closed off and sealed so as to prevent contaminants from entering the bag and for providing a seal that is destroyed when the bag is opened.
In a known specimen bag, a transparent flexible bag is provided defined by opposing wall panels with one of the wall panels having a slit therein for access to the inside of the bag. Moreover, such a prior art bag is known to include a strip of adhesive provided adjacent the slit on either side thereof or on both sides of the slit, which is covered by a backing strip. Thus, when the backing paper layer is removed, the adhesive is exposed and the bag can be sealed by folding the slit onto the adhesive strip.
An example of a flexible plastic sample bag including an opening with an adjacent adhesive strip covered by a protective strip can be found in U.S. Pat. No. 3,819,106 to Schuster. Another example of a known specimen bag comprises a similar flexible plastic bag including a slit in one of the opposed wall panels, wherein an adhesive layer is provided on both sides of the slit with a protective strip thereover. In both of the above examples, the protective strip is removed and the bag is folded so that the slit engages the adhesive strip for sealing.
Other prior art flexible bags including access openings in a side wall with an adhesive closure are shown and described in U.S. Pat. Nos. 3,655,118 to Rinecker, 4,550,831 to Whitford, and 4,786,190 to Van Erden et al. Of these, the Rinecker and Van Erden et al. flexible bags are specifically provided with closure devices allowing reopening and closing of the closures many times.
None of the afore-mentioned prior art bags, however, contemplate the provision of any type of tamper-indicating or identification label on the bag for use on the specimen.
Heretofore, if such a specimen label was to be used in conjunction with a specimen bag for being adhered to a specimen that will be placed within the bag, it was necessary to bring along a separate specimen label for that purpose. More specifically, in a typical situation, a specimen taker would have a plurality of specimen bags on hand and would also have a roll or stack of adhesive-backed labels of the peel-and-stick type which could be adhered to the specimen prior to insertion within the bag. Such a situation is disadvantageous in that it is inconvenient to have to carry or have available both a separate bag and a separate specimen label in order to take a specimen, particularly when the specimen is taken at a remote location. Moreover, when relying on the bag to establish chain-of-custody, it is imperative that it can be shown that the flexible bag was sealed in a condition with the specimen sealed therein. If one had only the bag available and had forgotten or misplaced the specimen label, he would not be able to seal the bag until the specimen was correctly labeled. To seal the bag at a location other than the specimen-taking location would compromise the chain-of-custody which could not then be definitely established. When dealing with such a chain-of-custody situation, it is necessary that all activities concerning the specimen be completed at the location that the specimen is taken so that once the specimen is sealed within the flexible chain-of-custody bag the specimen will not be tampered with. This is, of course, what establishes the chain-of-custody.
Regarding the basic use of labels in combination with a flexible bag or package, a reusable mailing device is disclosed in U.S. Pat. No. 3,151,803 to Kaminski. The Kaminski mailer has an access slit through one wall panel and an adhesive address strip which is used not only to indicate where the package is to go but also to seal the slit. However, the address strip is adhered directly on the envelope, as opposed to being adhered to an article inserted in the mailer, after it is filled out and is thrown away after opening. The Kaminski device is reusable only by putting a new address label over the slit for closing the envelope for each usage of the envelope.
In another type package, a pocket is provided on a package within which indicia bearing material can be contained which is visible from the outside of the package, as shown in U.S. Pat. No. 2,793,743 to Lefebvre.
In Lefebvre, the package as well as the pocket can be sealed by a seperate adhesive strip on the bag. In both Kaminski and Lefebvre, the disclosed labels are strictly used to be visible on the outside of the package and are not used on any article provided inside the bag or package. Moreover, none of the prior art specimen or other type bags disclose a label removably secured to the bag or package which is then used on an article.